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Drug FDA Class II Ongoing Quality

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Pro

AsttraZeneca Pharmaceuticals LP Published May 28, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact AsttraZeneca Pharmaceuticals LP or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective delivery system

Affected products (1)

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .

AIRSUPRA · a) 807,837 canisters; b) 235,698 canisters

NDC: 0310-9080, 0310-9080-12, 0310-9080-28
Lot codes: 6270019E00
Code info: Lot#: a) 6270044C00, 6270040D00, 6270034E00, Exp Date 10/2026; 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00 Exp 11/30/2026; 6270064C00, 6270071D00, 6270075D00, 6270075F00 Exp Date 12/31/2026; 6270107C00, Exp Date 9/30/2027; b) Lot 6270019E00, Exp Date 7/31/2025; 6270021D00, Exp 8/31/2025; 6270095C00, Exp 2/28/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    May 14, 2025
  2. Published
    May 28, 2025
Recall number
D-0444-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.